Quality Assurance Engineer

agap2 Switzerland; Basel; On-site; CHF 60,000 - 90,000; Full time

Job summary

agap2 Switzerland is seeking a consultant to support our clients on site, ensuring QMS maintenance and continuous improvement. The role involves drafting GMP docs, reviewing batch records, and overseeing QA activities across CMOs and subcontractors.

You will work in an international, cross-functional environment, requiring strong GMP knowledge, biotech manufacturing understanding, and fluent English and German communication. This position is based in Basel, Switzerland.

Qualifications

• Degree in Pharmacy, Engineering, Biotechnology, or Quality Management.
• Experience in biotechnology or biopharmaceutical industry.
• Understanding of USP, DSP, and Fill & Finish processes.
• Fluency in English and German (written and spoken) mandatory.

Responsibilities

• Ensure the maintenance and continuous improvement of the Quality Management System (QMS).
• Prepare batch release documentation, including detailed review of batch records.
• Draft, review, and approve GMP-related documentation.
• Review and approve biotechnology process validation documentation (validation plans, protocols, and reports).
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee quality activities related to subcontractors and CMOs, including qualification and performance monitoring.
• Develop, update, and maintain quality procedures and SOPs.
• Prepare Annual Product Quality Reviews (APQRs).
• Conduct internal audits and provide support during regulatory inspections.

Skills

GMP knowledge

Cross-functional

Biotech manufacturing

Bilingual EN/DE

Education

PharmD

Engineering

Biotechnology

Quality Management

Tools

QMS

CAPA system

Job description

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Main Responsibilities

• Ensure the maintenance and continuous improvement of the Quality Management System (QMS)
• Prepare batch release documentation, including detailed review of batch records
• Draft, review, and approve GMP-related documentation
• Review and approve biotechnology process validation documentation (validation plans, protocols, and reports)
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints
• Oversee quality activities related to subcontractors and CMOs, including qualification and performance monitoring
• Develop, update, and maintain quality procedures and SOPs
• Prepare Annual Product Quality Reviews (APQRs)
• Conduct internal audits and provide support during regulatory inspections

Your Profile

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management
• Prior experience within the biotechnology or biopharmaceutical industry
• Strong understanding of biotechnological manufacturing processes, including USP, DSP, and Fill & Finish operations
• Good knowledge of cGMP regulations and quality standards
• Comfortable working in an international and cross-functional environment
• Fluency in both English and German, written and spoken, is mandatory

Thank you for your interest in this opportunity. Please note that only candidates selected for an initial interview will be contacted.